Counterfeit Drugs: Toyota's Highest Ranking Female Employee Arrested; It's Time to Understand!

Counterfeit drugs: Toyota’s highest ranking female employee arrested; it’s time to understand!

Yesterday, on July 1, 2015, the Drug Supply Chain Security Act (or Drug Quality and Security Act) became effective in the United States.

The law is designed to secure the supply chain of medicines and restrict counterfeit drugs, an industry estimated to be bigger than Pfizer and GSK combined.

Laws against counterfeit drugs have also led to the arrest of Toyota’s highest-ranking female employee for alleged smuggling banned painkillers from the U.S. to Japan…

What exactly are counterfeit drugs?

An estimated market of $75 billion, by the World Health Organization’s own admission, “counterfeit drug is defined differently in different countries”.

What the FDA calls “fake medicine”, WHO calls any medicine, “which is deliberately and fraudulently mislabeled with respect to identity and/or source”.

For this reason, Toyota executive Julie Hamp’s efforts to “disguise illegal drug tablets” of painkiller oxycodone, legal with a prescription in the U.S., while a narcotic in Japan, would also fall under the same, loose classification.

Why is it such a big issue?

Counterfeit drugs present a big challenge for users of medicines since there is no easy way for patients to know whether or not the medicines they consume are safe.

The WHO believes that between 1% and 10% of drugs sold around the world are counterfeits and this number could be as high as 50% in some countries.

The primary distribution channel for such products are illegal pharmacies operating over the internet. However, it is when fake drugs get mixed with the normal medicine supply chain that countless horror stories get reported. We have decided to cover some headlines made in recent times.

Recent impact of counterfeit drugs

- 365 children died in Panama due to a “toxic cough syrup” in which pharmaceutical manufacturers used toxic brake fluid component, diethylene glycol instead of glycerine.

- FDA discovered that foreign distributors had supplied unapproved, counterfeit versions of Roche’s Altuzan 400mg/16ml (bevacizumab), an injectable cancer medication unapproved in the United States but approved in Turkey. Lab tests found that the injections contained no active ingredient.

- Counterfeit versions of orlistat (Alli), GlaxoSmithKline’s over-the-counter weight-loss medication, were distributed over the internet, which did not contain the active ingredient. The fake product had been made with varying amounts of a controlled substance called sibutramine instead (anorexiant, removed from the US market due to concerns about heart attack and stroke).

- A brand of Viagra in India, Kamagra, could not be sold outside India due to patent laws. So while Kamagra was not a counterfeit drug in India, the success of Kamagra made it available in other countries at prices much lower than Viagra.

- In early 2008, ‘fake’ heparin based medicines caused deaths in the U.S. and other parts of the world. Chinese producers, trying to realize cost saving opportunities, had added a potentially toxic substance called ‘over-sulphated chondroitin sulphate’ to pharmaceutical grade heparin. The counterfeit product was cheaper to make, did not offer the intended therapeutic effect and was difficult to differentiate with existing test methods.

- FDA discovered counterfeit versions of Roche’s cancer drug Avastin had entered the U.S. supply chain. Two Turkish nationals were arrested for shipping the drugs to the United States with false customs declarations.

- A physician, supplied with a research version of onabotulinumtoxinA (Botox), which was much more concentrated than the actual dosage, and not intended for human use. The research version resulted in respiratory paralysis and near death for several patients, including the physician who was using it himself.

A very profitable business

An expert estimates that counterfeit drugs are significantly more profitable than selling illegal drugs like heroin or cocaine. A $1000 investment in counterfeit prescription drugs can result in a $30,000 return, which is 10 times the profit rate of trafficking heroin. Another source reported that selling counterfeit Viagra (sildenafil) “can be as much as 2000 times more profitable” than selling cocaine.

Finally, the criminal penalties for the sale of counterfeit medications are far less than the penalties for selling illegal narcotics.

Given the variation in global prices of the same drug, supply of medicines with incorrect documentation through internet based models is common practice.

An international effort, Operation Pangea VIII, earlier in June, shut down 2,800 websites across, 115 countries and seized medicines worth $81 million.

Bring it on!

In addition to restricting the entry of counterfeit products at different ports, FDA scientists have developed a counterfeit detection device, CD-3. A battery-operated, hand-held and inexpensive tool, using CD-3 costs a fraction of the price of existing laboratory-based and field-deployable technologies.

Africa, where the counterfeit drug problem is the most prevalent, has also initiated trials of the CD-3 device.

While detection is only part of the solution, laws designed to implement product serialization, a comprehensive system to track and trace prescription drugs through the entire supply chain, have been drafted.

Challenges

The intent of track and trace systems is to enable comprehensive product traceability (down to lot number details) from the manufacturer to the patient.

Europe, India, Nigeria, Brazil, China have all announced measures to combat the counterfeit drug problem. However, there are differences in each country’s approach towards the implementation of product serialization.

The lack of harmonization, to achieve compliance in different countries, will impact production and packaging processes of many pharmaceutical manufacturers with global operations.

Given the scale of this endeavor, the U.S. planned implementation timeframes for the Drug Supply Chain Security Act are stretched across a 10-year period.

Digital solutions?

In the meantime, some pharmaceutical companies are already moving ahead of the curve. EMD Serono, part of Merck KGaA, launched a mobile application called Check My Meds ^TM for product verification and is already available for download for U.S. patients.

As some medicines and such apps are not available yet all over the world, where ever you are, it’s important to be careful, since problems with counterfeits can occur everywhere on the planet.

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Image Credit : CNBC AFRICA -- Derek, on 'Counterfeit Goods' by Roy Blumenthal is licensed under CC BY 2.0

“ The article is based on the information available in public and which the author believes to be true. The author is not disseminating any information, which the author believes or knows, is confidential or in conflict with the privacy of any person. The views expressed or information supplied through this article is mere opinion and observation of the author. The author does not intend to defame, insult or, cause loss or damage to anyone, in any manner, through this article.”

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